The following data is part of a premarket notification filed by Seca Corp. with the FDA for Seca Digital Baby Scale 727.
Device ID | K822135 |
510k Number | K822135 |
Device Name: | SECA DIGITAL BABY SCALE 727 |
Classification | Scale, Patient |
Applicant | SECA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRW |
CFR Regulation Number | 880.2720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-20 |
Decision Date | 1982-07-30 |